Supportive-Expressive and Emotion-Focused Treatment for Depression

NCT04576182 | Recruiting DMC

• 1 other identifier: ISF 395/19
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the mechanisms of change that are activated when individuals receive a treatment that targets their weakness and the mechanisms activated when the treatment capitalize on their strength. Patients will be assigned to one of two types of psychotherapies in treating people with a major depression disorder, expressive-supportive vs. emotion-focused treatment. Their ability to benefit from treatment based on their pre-treatment levels of insight and emotional processing will be examined. This is a four-month protocol, with a 2 year follow up period.

Conditions

Major Depressive Disorder

Keywords

Psychotherapy; Mechanism of change; supportive-expressive treatment; Emotion-Focused Therapy; Psychodynamic psychotherapy; Insight; emotional processing

Outcome Measures

Primary Outcomes (1)

• Weekly change in Hamilton rating scale for depression (HRSD)

  A 17-item clinically administered measure assessing the severity of depression. Higher scores indicate worse outcome.

  up to 16 weeks.

Secondary Outcomes (4)

• Weekly change in Beck Depression Inventory (BDI)

  up to 16 weeks

• Weekly change in Outcome Questionnaire (OQ)

  up to 16 weeks

• Trajectories of change in Inventory of Interpersonal Problems (IIP-32)

  At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)

• trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)

  At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16)

Study Arms (2)

Supportive-Expressive

EXPERIMENTAL

Participants will receive supportive-expressive treatment for 16 weeks.

Behavioral: Supportive-expressive treatment

Emotion-Focused

EXPERIMENTAL

Participants will receive Emotion-Focused treatment for 16 weeks.

Behavioral: Emotions-Focused treatment

Interventions

Supportive-expressive treatment BEHAVIORAL

Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.

Supportive-Expressive

Emotions-Focused treatment BEHAVIORAL

Sixteen weeks of a brief experiential therapy for depression that combine client-centered relational elements (unconditional positive regard, congruence, and empathy) with marker-guided experiential interventions designed to facilitate and deepen emotional processing and emotion regulation.

Emotion-Focused

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting major depressive disorder diagnostic criteria using the structured clinical interviews for Diagnostic and Statistical Manual of Mental Disorders-5 and scoring more than 14 on the 17-item Hamilton rating scale for depression at two evaluations (one week apart) (Hamilton, 1967).
• If on medication, patients' dosage must be stable for at least three months prior to entering the study, and they must be willing to maintain stable dosage for the duration of treatment
• Age between 18 and 65
• Hebrew language fluency
• Provision of written informed consent.

You may not qualify if:

• Current risk of suicide or self-harm
• current substance abuse disorders
• current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
• history of organic mental disease
• currently in psychotherapy

Sponsors & Collaborators

• University of Haifa: lead
• Israel Science Foundation: collaborator

Study Sites (1)

University of Haifa

Haifa, Israel

RECRUITING

Related Publications (1)

• Zilcha-Mano S, Shahar B, Fisher H, Dolev-Amit T, Greenberg LS, Barber JP. Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial. BMC Psychiatry. 2021 Jun 2;21(1):287. doi: 10.1186/s12888-021-03279-y.

  PMID: 34078324 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Sigal Zilcha-Mano, PhD

CONTACT

972-8249047; sigalzil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (participants, outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: October 6, 2020
• Study Start: November 29, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)